BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000

    MDR report key: 10991706 · Received December 11, 2020

    Report

    Report Number
    3016438761-2020-00330
    Event Type
    Malfunction
    Date Received
    December 11, 2020
    Date of Event
    November 24, 2020
    Report Date
    January 11, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740000509
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TICKET TRENDING DID NOT IDENTIFY ANY COMPLAINTS THAT WERE SIMILAR FOR FALSELY ELEVATED SODIUM PATIENT RESULTS. THE TREND REVIEW BY THE PRODUCT LIST NUMBER FOUND NO TRENDS RELATED TO THIS ISSUE. A REVIEW OF THE CLINICAL CHEMISTRY SYSTEMS TRACKING AND TRENDING DATA REVEALED NO SYSTEMIC ISSUES OR TRENDS ASSOCIATED WITH THE DISCREPANT RESULTS DESCRIBED IN THIS COMPLAINT. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSELY ELEVATED SODIUM RESULT GENERATED ON THE ARCHITECT C8000 ANALYZER ON ONE PATIENT. RESULTS PROVIDED: (B)(6) 2020 SID (B)(6)= 193.4 MMOL/L, ANOTHER ARCHITECT = 133.95 MMOL/L; NORMAL RANGE: 133-147 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457003 ARCHITECT C8000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 1G06-11 00380740000509

    Patients

    Seq Age Sex Outcome Treatment
    1